Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:36 PM
Ignite Modification Date:
2025-12-24 @ 12:36 PM
NCT ID:
NCT01069861
Eligibility Criteria:
Inclusion Criteria:
* 72 hours of age; and \> or = to 34 weeks gestational age.
* Persistent Pulmonary Hypertension of the Newborn or Hypoxic respiratory failure associated with:
1. Idiopathic PPHN or
2. Meconium aspiration syndrome or
3. Sepsis or
4. Pneumonia
* Oxygenation Index (OI) \>15 and \<60 calculated
Exclusion Criteria:
* Patients already receiving inhaled nitric oxide (iNO) on referral.
* Prior or immediate need for full Cardio Pulmonary Resuscitation or Extracorporeal Membrane Oxygenation (ECMO).
* Life threatening or lethal congenital anomaly.
* Large left to right intracardiac or ductal shunting (diagnosed from echocardiogram on admission to GOSH).
* Clinically significant active seizures as per clinical judgment.
* Bleeding diathesis as per clinical judgment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Hour
Maximum Age:
72 Hours
Study:
NCT01069861
Study Brief:
Protocol Section:
NCT01069861